The following data is part of a premarket notification filed by Northeast Monitoring, Inc. with the FDA for Dr180+oxy.
| Device ID | K004007 |
| 510k Number | K004007 |
| Device Name: | DR180+OXY |
| Classification | Recorder, Magnetic Tape, Medical |
| Applicant | NORTHEAST MONITORING, INC. 730 BOSTON POST RD. SUITE 23 Sudbury, MA 01776 |
| Contact | Rodney L Cambre |
| Correspondent | Rodney L Cambre NORTHEAST MONITORING, INC. 730 BOSTON POST RD. SUITE 23 Sudbury, MA 01776 |
| Product Code | DSH |
| CFR Regulation Number | 870.2800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-12-26 |
| Decision Date | 2001-01-25 |